Inside Health Policy | FDA Inspection Plans Unclear as EUAs Move toward Full Approvals

This week, members of the House of Representatives elected Representative Mike Johnson (R-LA-4) as the new Speaker and the Health Resources and Services Administration (HRSA) issued a notice of registration requirements for off-site, outpatient hospital facilities to participate in the 340B Drug Pricing Program.

This week, Congress passed a bill raising the nation’s debt limit to avoid a potential default and CMS issued a final rule rescinding COVID-19 vaccine requirements for facilities participating in Medicare and Medicaid. 

Cathy Burgess comments on how the U.S. Food and Drug Administration is likely to use remote evaluations to resolve as many issues as possible before returning to onsite inspections of facilities.

Cathy Burgess is quoted on COVID-19 safety considerations for Food and Drug Administration inspections.